In today’s rapidly evolving food industry, innovation is key to meeting consumer demands and preferences. However, with innovation comes the responsibility to ensure the safety and compliance of novel food products. In India, the Food Safety and Standards Authority of India (FSSAI) plays a pivotal role in regulating and overseeing the approval process for such products. Understanding the FSSAI regulations governing novel food products is essential for food businesses aiming to bring new products to market.
What is it?
By definition, a novel food product or, in regulatory terms, a non-specified food means any food other than proprietary food or food ingredients, including additives, processing aids, and enzymes for which standards have not been specified in any regulation made under the Act. [Ref: FSS (Approval for Non-Specific Food and Food Ingredients) Regulation, 2017].
These include:
- Novel Food
- Novel food product
- Novel food ingredient
- Processed using novel technology
2. Additives – not listed in Food Safety and Standards Regulations (FSSR)
3. New processing aid/enzyme – not listed in FSSR
4. Non-specified food –
a. New botanical
b. New fruit or fruit-based product
c. Probiotic and Prebiotic
d. Any other
GM-origin foods are currently not permitted under FSSR.
The Approval Process:
Navigating the approval process for non-specific food and food ingredients requires a strategic approach. Here’s a glimpse into the roadmap:
1. Preparation Phase: Before embarking on the approval journey, food businesses must conduct thorough research and gather comprehensive data on the non-specific food or ingredient in question. This includes information on its composition, intended use, safety considerations, and many more other requirements.
2. Application Submission: Food businesses submit their application for approval to the FSSAI along with the fees of Rs. 50000/- + GST. The application must include detailed information on the non-specific food or ingredient, along with supporting documentation and suitability for use in food products.
3. Safety Assessment: The safety assessment is conducted by the FSSAI’s expert panel. This assessment scrutinizes the potential health risks associated with the non-specific food or ingredient, and the associated risks to human health.
4. Queries/ clarifications: The authority shall revert to the applicant within 45 days of submission of the application in case any further documents or clarifications are required to help them take the decision. The FBO shall revert with clarifications within 30 days.
5. Review and Decision-making: Following this, the FSSAI reviews the application, considering the scientific evidence presented, compliance with regulatory standards, and any other relevant factors. Based on this review, the FSSAI decides on the approval of the non-specific food or ingredient, which may include granting approval with specific conditions or requesting additional information.
6. Post-approval Monitoring: Even after approval is granted, the journey doesn’t end there. The FSSAI maintains vigilance through post-market surveillance and monitoring mechanisms, ensuring that the non-specific food or ingredient continues to meet safety standards and regulatory requirements.
Additional information that may be asked during the process (non-exhaustive list):
- Detailed composition of product
- Scientific rationale for combining different ingredients
- Supporting document on the information on the synergistic or antagonistic effect of the combination
- Proposed label of the product
- End use declaration
- Supporting document – systematic review, human intervention studies
- Detailed method of analysis & technical specification
How can Food Safety Works help?
Navigating the maze of regulations governing the approval process for manufacturing and selling novel foods in India demands meticulous attention to detail. This intricate procedure requires expert guidance to navigate the labyrinth of requirements and submit applications to the appropriate authorities.
The journey begins with understanding the regulatory landscape, a complex tapestry of rules and standards set forth by the Food Safety and Standards Authority of India (FSSAI). With the help of seasoned professionals at Food Safety Works, businesses can identify the specific requirements and compile the necessary documentation to initiate the approval process.
Each step must be executed with precision, as even the slightest error in documentation could lead to delays in approval. From comprehensive safety assessments to detailed labeling requirements, every aspect of the application must adhere to strict regulatory standards.
In conclusion, obtaining approval for importing, manufacturing, and selling novel foods in India is a complex undertaking that requires expert guidance and meticulous attention to detail. We at Food Safety Works can help to understand the requirements and make the process smooth for you.
